Generic Aricept and Other Cholinesterase Inhibitors

[diana.papshev]

Anonymous member request:

"Any knowledge on how Aricept generic got approved 1 yr before settlement with Teva was to occur? Any information/theories would be greatly appreciated!"

[chantell.reagan]

Please see the information regarding the Aricept generic and other ChEI's below:



Aricept tablet

First generic approval/launch forecast:

o Expected by 11/25/2010

Background, details, and sources:

o All currently listed patents expire by 3/2019 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed starting prior to 2004 (Teva appears to be eligible for the 180-day exclusivity). Eisai filed patent infringement lawsuits against these companies. At issue is the enforceability of the ‘841 patent, which is set to expire on 11/25/2010. It appears that litigation is still ongoing. (Sources: FDA paragraph IV list; Patent Docs, 12/09; FDA’s Orange Book)
o Starting in 1/2007, the FDA issued tentative approvals for various manufacturers including Ranbaxy, Par, Roxane, Apotex and Aurobindo. In 4/2008, Teva has received final FDA approval due to the expiration of the 30-month stay. However, U.S. District Court has granted a preliminary injunction against Teva until the trial can be held. (Sources: Drugs@FDA; Teva Press release 3/08; Bloomberg.com news release 3/08)

Aricept ODT

First generic approval/launch forecast:

o Expected after 11/25/2010

Background, details, and sources:

o All currently listed patents expire by 11/25/2010 (Sources: FDA’s Orange Book)
o No ANDA with paragraph IV certification has been filed. However, Mutual Pharma (now URL) filed ANDA in 11/2005 without any patent certifications since at that time the ‘841 patent (which expires in 11/2010) was not listed in the Orange Book. Eisai filed patent infringement lawsuit against Mutual/URL; in 12/2007 district court dismissed the case but Mutual/URL was required to notify Eisai of any product launch within 45 days so that Eisai can seek injunctive relief against Mutual's sales. (Sources: FDA’s list of Paragraph IV patent certifications; Eisai court complaint, 4/2007; Eisai press release, 12/2007)
o Mutual/URL received approval for the generic Aricept ODT in 12/09, but the company announced that it will not launch until the ‘841 patent expires in 11/2010 (Sources: Drugs@FDA; Mutual Pharma press release 12/09)

Cognex

First generic approval/launch forecast:

o Pending ANDA filing/approval

Background, details, and sources:

o There are no unexpired patents or exclusivities (Sources: FDA’s Orange Book)
o No ANDA with paragraph IV certification has been filed (Sources: FDA’s list of Paragraph IV patent certifications)
o The FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

Exelon capsule

First generic approval/launch forecast:

o Expected between late 2013 and 2/11/2014

Background, details, and sources:

o All currently listed patents expire by 2/11/2014 (Sources: FDA’s Orange Book)

o Starting in 4/2004, at least 1 ANDA with a paragraph IV certification has been submitted (by Dr Reddy’s, Watson, Sun). Novartis pursued all filers and starting in 12/2007 all cases have been settled to allow sales of generic products some time before the expiration of all patents (exact date was not released) (Sources: FDA’s list of Paragraph IV patent certifications; Dr Reddy’s press release, 1/2008; Watson press release, 12/2007; Sun press release, 12/2007)
o Starting in 10/2007, the FDA issued final approvals for the generic product of Dr Reddy, Sun, and Watson; however, these products were not launched based on the settlement terms (Sources: Drugs@FDA)

Exelon solution

First generic approval/launch forecast:

o Expected by 2/11/2014

Background, details, and sources:

o All currently listed patents expire by 2/11/2014 (same patents as for the capsule formulation) (Sources: FDA’s Orange Book)
o At least 1 ANDA with a paragraph IV certification has been submitted; however, records on the related litigation could not be located in the public domain. (Sources: FDA’s list of Paragraph IV patent certifications; Novartis SEC filing, 1/2009)
o In 12/2005, Ranbaxy received tentative approval for its generic version (Sources: Drugs@FDA)

Exelon patch

First generic approval/launch forecast:

o Expected by 8/2019

Background, details, and sources:

o All currently listed patents expire by 8/2019 (Sources: FDA’s Orange Book)
o No ANDA with paragraph IV certification has been submitted yet; NDF (new dosage form) exclusivity is effective until 7/6/2010. (Sources: FDA’s list of Paragraph IV patent certifications)
o The FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

[chantell.reagan]

Sun and Watson launch their generic rivastigmine capsules 7/1/10, with both companies sharing 180-day marketing exclusivity per settlement with Novartis (sources: Watson press release 7/10; Sun press release 7/10)

[chantell.reagan]

Ranbaxy launched generic donepezil on November 30, 2010 and has been awarded 180-day exclusivity.

Source: Ranbaxy press release 11/30